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April 9, 2020

Abbott's TriClip Receives CE Mark Approval for Transcatheter Tricuspid Valve Repair

April 9, 2020—Abbott announced that its TriClip transcatheter tricuspid valve repair system has received European CE Mark approval as a nonsurgical treatment for tricuspid regurgitation (TR) in Europe and countries that recognize the CE Mark.

The TriClip procedure delivers the device through the femoral vein and works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood. This approach allows the heart to pump blood more efficiently, relieving symptoms of TR, and improving the patient's quality of life.

According to Abbott, the European approval of the TriClip device was supported by data from the pivotal TRILUMINATE trial. Six-month data from TRILUMINATE that examined the edge-to-edge repair technique using TriClip, demonstrated that TriClip reduced the severity of TR and was associated with strong improvement in functional capacity and in quality of life. In November 2019, Prof. Georg Nickenig, MD, et al published the TRILUMINATE data in The Lancet (2019;394:2002–2011). Prof. Nickenig, who is professor and chief, Department of Cardiology, University Hospital, Bonn, Germany, served as Lead Investigator of TRILUMINATE.

In the company's announcement, Prof. Nickenig commented, "Patients suffering from severe tricuspid regurgitation are extremely ill and have very few treatment options. Abbott's TriClip could profoundly impact how physicians treat these patients. The therapy is backed by data proving safety and performance, durability, and improved patient quality of life."

The company stated that the TriClip leverages the same clip-based technology as Abbott's MitraClip device for the treatment of mitral regurgitation but has a differentiated delivery system designed specifically for delivery to the tricuspid valve. The TriClip's new, steerable guiding catheter system adapts to the right side of the heart, where the tricuspid valve resides, enabling the physician to effectively grasp and clip the leaflets of the tricuspid valve. Additionally, the TriClip device is available in two different sizes (NT and XT) to accommodate different patient anatomies.

The TriClip transcatheter tricuspid valve repair system is an investigational device only in the United States, advised Abbott.

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